# Intismeran autogene

Source: https://onco.cc/drugs/intismeran-autogene/  
OnCo record `intismeran-autogene` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A custom mRNA vaccine encoding up to 34 of a patient's own tumour mutations. In August 2026 it became the first personalised cancer vaccine to win a phase 3 trial.

## Summary

Intismeran is developed by Moderna and Merck. Phase 2b KEYNOTE-942 showed 49% reduction in recurrence or death with pembrolizumab in resected melanoma. Phase 3 INTerpath-001 (1,137 patients, stage IIB-IV resected melanoma) met RFS and DMFS endpoints (19 August 2026); regulatory filings expected. Phase 3 trials in adjuvant NSCLC (INTerpath-002), RCC, bladder, and cutaneous SCC ongoing. Manufacturing ~6 weeks per patient.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-04
- Also known as: mRNA-4157; V940; personalised cancer vaccine (PCV); individualised neoantigen therapy (INT)
- Code: V940, mRNA-4157
- Modality: Personalised mRNA neoantigen vaccine
- Mechanism: Tumour/normal WES → neoantigen prediction → single mRNA encoding up to 34 neoepitopes in LNP → intramuscular dosing with pembrolizumab.
- Dosing: Intramuscular injection; 1 mg every 3 weeks for up to 9 doses, with pembrolizumab 200 mg every 3 weeks for up to 18 cycles

## Sources

- Merck/Moderna announcement: https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Melanoma](https://onco.cc/cancers/melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Stage IIB and IIC melanoma](https://onco.cc/cancers/stage-ii-melanoma/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- technologies: [mRNA and lipid nanoparticle manufacturing](https://onco.cc/technologies/mrna-lnp-manufacturing/), [Personalised neoantigen (mRNA) vaccines](https://onco.cc/technologies/neoantigen-mrna-vaccine/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Merck & Co. (MSD)](https://onco.cc/companies/merck/), [Moderna](https://onco.cc/companies/moderna/)
- trials: [A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)](https://onco.cc/trials/nct06833073/), [A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)](https://onco.cc/trials/nct06961006/), [A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)](https://onco.cc/trials/nct06305767/), [A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I ](https://onco.cc/trials/nct07513376/), [A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).](https://onco.cc/trials/nct06307431/), [A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (](https://onco.cc/trials/nct06077760/), [A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)](https://onco.cc/trials/nct07221474/), [A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)](https://onco.cc/trials/nct06623422/), [An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYN](https://onco.cc/trials/nct03897881/), [INTerpath-001 (V940-001)](https://onco.cc/trials/interpath-001/)
- terms: [Cancer vaccines and oncolytic viruses](https://onco.cc/terms/vaccines-and-oncolytic-viruses/), [Neoantigen](https://onco.cc/terms/neoantigen/)
- pairings: [Personalised neoantigen vaccine + PD-1 blockade](https://onco.cc/pairings/vaccine-plus-pd1/)
- people: [Jeffrey S. Weber](https://onco.cc/people/jeffrey-weber/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- ideas: [Personalised cancer vaccines at commodity cost through fully automated manufacturing](https://onco.cc/ideas/idea-moon-neoantigen-vaccines-at-scale/), [Personalised vaccines given only when the blood test turns positive](https://onco.cc/ideas/idea-bio2-mrd-triggered-neoantigen-vaccine/), [What makes a neoantigen actually immunogenic?](https://onco.cc/ideas/idea-neoantigen-immunogenicity-rules/)
- key papers: [KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery](https://onco.cc/key-papers/paper-keynote-942-lancet-2024/), [Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer](https://onco.cc/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/)
- pathways: [The cancer-immunity cycle](https://onco.cc/pathways/cancer-immunity-cycle/)

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